Product code OME

Device name

Extracorporeal Shock Wave Treatment

Medical specialty

Unknown

Device class

3

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

For use for extracorporeal shock wave treatment of atrophic nonunion fractures. The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal.

Source

FDA openFDA device classification dataset